Biotectix, LLC, an Allied Minds, Inc. subsidiary, is pleased to announce the first-in-human (FIH) use of an electrostimulation device incorporating its BT DOT conductive polymer coating technology. Last month, patients were surgically implanted with novel gastric stimulation devices utilizing electrodes coated with Biotectix's proprietary material. The FIH achievement represents a significant step toward commercialization of a core Biotectix product, BT DOT. Biotectix also continues to work with a number of partners developing the next generation of chronically implanted electrical stimulation and recording devices for a variety of applications.
Dr. Jeffrey L. Hendricks, Director of Engineering at Biotectix, was present during the surgical procedures and noted that, "The BT DOT coating allowed our partner to use a much smaller electrode and lead assembly than they have previously implanted. The assembly was also easier and faster for the surgeon to implant, which should result in reduced trauma to the patient, more reproducible orientation, and better placement. Early results also suggested the coated electrodes may enable faster and more effective stimulation of the GI tract."
The trial is the culmination of several months of activity with the device partner, from initial development and demonstration of the BT DOT coating on prototype designs in vitro to completion of stability, sterilization, and durability testing. In the final phases, devices suitable for human uses were prepared and necessary IRB documentation was submitted and approved prior to initiation of the study. Treatment of additional patients is anticipated in the coming months.
Dr. James Arps, General Manager at Biotectix, remarked, "The first human implants of devices incorporating the BT DOT technology is a tremendous accomplishment for Biotectix in demonstrating the safety and efficacy of our proprietary coating materials. This is the first of a number of successful clinical studies that we hope to complete with our various partners in the coming year."
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